Cerebral Embolic Protection: Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Study summary
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.
This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Subjects must meet ALL of the following criteria:
General Inclusion Criteria
* Age ≥18 years
* Severe Mitral Regurgitation (3+ to 4+)
* Symptom status: NYHA functional class ≥ II
* Subjects scheduled to receive the M-TEER per the current approved indications for use
* Subjects agreed to join the study and complete follow-up
Exclusion Criteria:
Potential Subjects will be excluded if ANY of the following criteria apply:
General Exclusion Criteria
* Contraindication to MRI
* CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
* Cerebrovascular accident within prior 30 days
* Severe symptomatic carotid stenosis (\>70% by ultrasound)
* Carotid surgery or stenting within prior 30 days
* Hemodynamic instability requiring inotropic support or mechanical heart assistance
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
* Contraindication for transesophageal echocardiography
* Life expectancy \< 1 year
* Pregnant or planning pregnancy within next 12 months
* Participation in another interventional Trial
* Patients who are not able to give consent or complete the follow-up
Primary outcome measure(s)
Total amounts of new lesions — 72 hours Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Sun Yat-sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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